There are currently ten COVID-19 vaccines being announced their preliminary efficacies from phase 3 clinical trial, and nine of them have been authorized for emergency use or conditional licensed, which brings some issues to present placebocontrolled efficacy trial of other COVID-19 vaccines. The approval of “first wave” COVID-19 vaccines raises concerns about the administration of a placebo in ongoing and future phase 3 trials of COVID-19 vaccine candidates. Comprehensive efficacy assessment strategy for the next steps is now required. This perspective covers challenges for ongoing COVID-19 vaccine clinical studies and alternative clinical study designs in the future, under the placebo use being acceptable or unacceptable circumstances, respectively, in order to ensure the safety, efficacy and effectiveness evaluation of COVID-19 candidate vaccines pre- and post-licensure.

目前有10种COVID-19疫苗在3期临床试验中公布了初步疗效，其中9种已获准紧急使用或有条件许可，这给目前其他COVID-19疫苗的安慰剂对照疗效试验带来了一些问题。“第一波” COVID-19 疫苗的批准引起了人们对在 COVID-19 候选疫苗正在进行和未来的 3 期试验中使用安慰剂的担忧。现在需要对下一步进行全面的功效评估策略。这一观点涵盖了未来正在进行的 COVID-19 疫苗临床研究和替代临床研究设计的挑战，分别在安慰剂使用可接受或不可接受的情况下，以确保安全，